Regulatory Compliance and Mobility: Clashing or Complementary Forces?

Posted on April 24, 2014 under Advice by

For companies that operate in regulated industries, mobile workforces and compliance officers can be perceived as clashing forces, but is this really the case?

Since many regulatory compliance requirements relate to the management of confidential information and associated workflows, a bring your own device (BYOD)-enabled workforce changes compliance-related content management. Regulated businesses must be able to protect content that is accessible from mobile devices, and they need to ensure that mobile phones and tablets are being used appropriately when employees participate in compliance-related workflows.

The corporate boundaries have also shifted in the BYOD world. Without adequate controls in place, any content accessible from a mobile device can be taken into the cloud, beyond the virtual walls of the company intranet. Highly-regulated companies have traditionally been hesitant to deploy cloud solutions, but smart phones, tablets, and laptops are literally bringing the cloud to their doorsteps.

Compliance-Friendly Mobile ECM Platforms Address Concerns of Regulated Businesses

Fortunately, some enterprise content management (ECM) solutions, such as M-Files, have been evolving in pace with the world of smart mobile devices. Mobile-friendly ECM platforms are being compliance and mobile content managementadopted by many regulated companies because they give employees the freedom and flexibility of anytime, anywhere access to corporate resources while simultaneously providing the workflow capabilities and access control systems necessary to support and enhance regulatory compliance activities.

Think about the use cases for mobile devices that are integrated into compliance-centric ECM environments. An electronic signature can be facilitated from a company- or employee-owned mobile device in instances when email attachments and online file sharing platforms are not viable options. Beyond convenience, this capability actually improves workflow efficiency while fulfilling the most stringent regulatory compliance requirements such as those associated with FDA 21 CFR Part 11.

Case in Point: Mobile SOP Management

Let’s look at this specific example: a regulated business needs to confirm that a manager who is out of the office has read and approved a major revision made to a standard operating procedure (SOP). An ECM platform with support for electronic signatures allows for the SOP author to move the document into the ‘Waiting for Approval’ state. An automatic notification is sent to the manager’s mobile ECM app, and the manager can review the changes and immediately approve the document for use with a compliant electronic signature.

An ECM platform with support for electronic signatures allows for superior SOP management

Other mobile device features are driving similarly beneficial use cases. Built-in cameras make it easier for employees to capture documents or evidence of a completed task such as replacing a recalled part in a vehicle or a bedside medical instrument. And mobile devices with GPS capabilities allow compliance officers to take advantage of location-based search functions to capture further proof of compliance and improve oversight

As I’ve noted in the recent articles I’ve written for DOCUMENT Media and Manufacturing Business Technology, regulated companies can experience significant benefits by allowing their staff to use mobile devices for compliance-related content and process management-related activities. From providing mobile access to information employees are authorized to access, edit and share — to streamlining workflows and automating compliance procedures, regulated companies can make their staff more productive while maintaining control over confidential information and ensuring ongoing regulatory compliance.

About Mika Javanainen

Mika is in charge of managing and developing M-Files product portfolio, roadmaps and pricing globally. As a Director of M-Files Product Management Unit, he leads and supervises M-Files Product Managers and works closely together with M-Files Product Development and Marketing teams to design and develop new products and features leveraging his long experience with ECM and M-Files technology. Mika has executive MBA Diploma in International Business and Marketing.

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